Program Overview

The OBA Internal Audit Exchange Program is designed for OBA members who are in a regulated GxP industry and maintain Quality Management Systems.  This includes companies associated with medical devices, diagnostics, biologics, pharmaceuticals, or analytical laboratories.  These industries typically require that companies monitor the effectiveness of their Quality Management System by performing routine internal audits to ensure overall compliance. Since many OBA member companies are small to medium in size, they often find themselves resource limited, leading them to hire independent consultants to perform internal audits.  Depending on the nature of the business and location of sales, the governing regulations and standards may vary and may include more than one regulation or standard.  Examples may include ISO 13485, ISO 9000, 21CFR Part 820, 21CFR Part 211, and directives such as EU MDD, IVDD, AIMDD, and Canadian Medical Device Regulation.

Over the past five years, three OBA member companies have developed a successful program to exchange auditors between their companies to conduct internal audits and maintain compliance.  OBA is now expanding it to all OBA members as a member-only benefit.

Interested companies will complete a questionnaire for the IAEP database.  Information required will include contact information, the quality standard you are complying with, and a short summary of your auditor(s) experience.  The exchange between the two companies will be a self-driven process by participants.  The OBA requires that the companies provide feedback to ensure continuous improvement and OBA member satisfaction.  

The IAEP Committee has also developed a guidance document that will assist the host companies and the internal auditors in conducting a successful and valuable exchange audit. [Guidance document coming soon]

In addition, the IAEP seeks OBA members who are interested in providing opportunities for internal auditors in-training to participate and shadow during internal audits.  This is a great chance for auditor trainees to learn and experience the auditing process firsthand.  The trainee auditor may be from the host company, the auditor's company, or even another IAEP participating company.   

Roles and Responsibility of Committee

The IAEP steering committee is responsible for the overall program requirements of the IAEP:

• implementation of a short application process
• general IAEP guidelines
• training and mentoring programs applicable to internal audits
• an evaluation process to monitor the program success and effectiveness

 

If you or your company is interested in participating in the IAEP program or on the IAEP steering committee, please contact Heather Deibele at heather@foxhillsconsulting.com.

Internal Audit Exchange Program Committee Participant Area (requires login)

Internal Audit Exchange Program Committee Secure Area (requires login)